Visine Red Eye Hydrating Comfort Solution/ Drops
NDC Package 67751-198-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Visine Red Eye Hydrating Comfort (tetrahydrozoline hydrochloride and polyethylene glycol 400) solution/ dropses is adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a daychildren under 6 years of age: consult a doctorchildren under 2 years of age: do not use. This formulation utilizes a solution/ drops delivery system. Marketed by Navajo Manufacturing Company Inc., this product is identified by NDC 67751-198 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
67751-198-01
Package Description
1 BOTTLE, DROPPER in 1 BLISTER PACK / 8 mL in 1 BOTTLE, DROPPER
Product Code
67751-198
11-Digit Billing Format
67751019801
RxNorm Crosswalk
  • RxCUI: 996209 - polyethylene glycol 400 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic Solution
  • RxCUI: 996209 - polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution
  • RxCUI: 996209 - PEG 400 1 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution

Clinical Specifications

Proprietary Name
Visine Red Eye Hydrating Comfort Eye Drops
Non-Proprietary Name
Tetrahydrozoline Hydrochloride And Polyethylene Glycol 400
Substance Name
Polyethylene Glycol 400; Tetrahydrozoline Hydrochloride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Usage Information
Adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a daychildren under 6 years of age: consult a doctorchildren under 2 years of age: do not use

Regulatory & Marketing

Labeler Name
Navajo Manufacturing Company Inc.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67751-198-01 identifies a specific commercial package of 1 bottle, dropper in 1 blister pack / 8 ml in 1 bottle, dropper of Visine Red Eye Hydrating Comfort Eye Drops, a human over the counter drug labeled by Navajo Manufacturing Company Inc.. This solution/ drops is formulated for ophthalmic use and contains polyethylene glycol 400; tetrahydrozoline hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Navajo Manufacturing Company Inc. on June 01, 2020. The current certification is valid through December 31, 2026.

How is this Navajo Manufacturing Company Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67751019801. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
67751-198-01
11-Digit CMS (5-4-2)
67751-0198-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.